Certified Pharmaceutical GMP Professional Practice

Master production and control records must be checked and signed by how many persons?

1. One person

2. Two persons

3. Three persons

4. Four persons

The correct answer is: Two persons

Master production and control records are critical components in the manufacturing process governed by Good Manufacturing Practices (GMP). These records ensure that production is consistent, compliant with regulatory requirements, and traceable in the event of discrepancies or investigations. The requirement for these records to be checked and signed by two persons is rooted in the principles of quality assurance and accountability. Having two individuals review and sign off on the master records serves as a control mechanism to reduce the risk of errors and ensure that procedures were followed correctly. The first individual typically verifies the accuracy and completeness of the records, while the second offers an additional layer of review as part of a quality control process. This dual checking system promotes accuracy, enhances safety, and fosters a culture of quality within the manufacturing environment. Adhering to this practice not only aligns with GMP guidelines but also reinforces the importance of teamwork and responsibility in the production process.